哈萨克斯坦伦理委员会的运作:结果和建议。

Lldar Fakhradiyev, Alfiya Shamsutdinova, Gulnara Kulkayeva, Bakhyt Sarymsakova, Darina Menlayakova, Almira Manatova, Saniya Saussakova, Anel Ibrayeva, Shynar Tanabayeva, Kerim Munir
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引用次数: 0

摘要

背景:从哈萨克斯坦各地的不同机构随机选择了16个RECs,代表了公共和私营部门,涵盖了生物医学和社会行为研究综述。目的:本研究通过提供哈萨克斯坦REC运营的经验数据,解决了一个关键的知识缺口,有助于更好地理解这些委员会如何与国际道德标准和最佳实践保持一致。此外,通过将我们的研究结果置于中低收入国家REC绩效的更广泛背景下,我们旨在突出哈萨克斯坦特有的具体挑战,并提出基于证据的建议。方法:采用基于有效自我评估工具的文化适应性半结构化问卷收集数据。采用描述性统计对数据进行分析。结果:RECs的总体平均得分为71.9%(满分为100%),表明功能总体有效,但突出了需要改进的重大领域。优势包括完善的组织方面,多样化的成员,和充分的教育培训。然而,在方案评估和资源分配的彻全性方面存在不足,“具体方案项目审查”(33.7%)和“REC资源”(56.2%)得分较低。此外,38.5%的RECs未在国家主管部门注册,这凸显了加强监管的必要性。结论:虽然哈萨克斯坦的RECs在组织结构和成员培训方面表现出优势,但在协议审查过程和资源支持方面存在重大差距。建议采取有针对性的干预措施——例如加强REC成员的培训项目、增加资金和资源以及建立一个国家认证系统——以提高研究中的伦理监督质量。加强这些领域将确保全面的方案审查和更好地保护研究参与者。
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The Functioning of Ethics Committees in Kazakhstan: Results and Recommendations.

Background: Sixteen RECs were randomly selected from various institutions across Kazakhstan, representing both public and private sectors and covering biomedical and socio-behavioral research reviews.

Objective: This research addresses a critical knowledge gap by providing empirical data on REC operations in Kazakhstan, facilitating a better understanding of how these committees align with international ethical standards and best practices. Furthermore, by situating our findings within the broader context of REC performance in LMICs, we aim to highlight specific challenges unique to Kazakhstan and propose evidence-based recommendations.

Methods: Data were collected using a culturally adapted, semi-structured questionnaire based on a validated self-assessment tool. Descriptive statistics were used to analyze the data.

Results: The overall average score for the RECs was 71.9% out of a possible 100%, indicating generally effective functioning but highlighting significant areas needing improvement. Strengths included well-established organizational aspects, diverse membership, and adequate educational training. However, weaknesses were identified in the thoroughness of protocol evaluations and resource allocation, with low scores in "Review of Specific Protocol Items" (33.7%) and "REC Resources" (56.2%). Additionally, 38.5% of RECs were not registered with national authorities, underscoring the need for improved regulatory oversight.

Conclusion: While RECs in Kazakhstan demonstrate strengths in organizational structure and member training, critical gaps exist in protocol review processes and resource support. Targeted interventions - such as enhancing training programs for REC members, increasing funding and resources, and establishing a national accreditation system - are recommended to improve the quality of ethical oversight in research. Strengthening these areas will ensure comprehensive protocol reviews and better protection of research participants.

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